Bioproduction solutions Date Name. 2 8/6/2015 | Life Technologies™ bioproduction solutions bioproduction solutions from molecule to market from molecule

Bioproduction solutionsDateName

2 04/21/23 | Life Technologies™

bioproduction solutionsbioproduction solutionsfrom molecule to marketfrom molecule to market

CellCellTherapyTherapy

Therapeutic Therapeutic Protein Protein

ProductionProductionMicrobialMicrobial

Expression and Expression and ProductionProduction

ViralViralVaccineVaccine

ProductionProduction

Products and services Working with us Why us? Summary

Setting new standards from molecule to marketIntroducing bioproduction solutions from Life Technologies

About us



Life Technologies is a global biotechnology leader dedicated to making life even better

• 160+ Countries served• $3.6B global leader• 1B$ Revenue in Pharma / Biotech space• 300M$ Revenue in Diagnostics space• 75000+ customers• 50,000 + products• 3,900+ patents and licenses• 10,000 employees• >1,000 New Product Introductions per year• Industry recognition as a life science leader

LifeTechnologies.com


Bioproduction is leading positive transformation in biologics production

• 24 of the Top 25* pharmaceutical companies worldwide use a LIFE bioproduction solution, many with multi-site adoptions

• A majority of future biotherapeutics currently in Phase 1-3 development use a LIFE bioproduction solution**

• A large number of launched biotherapeutics today are manufactured using a LIFE bioproduction solution***

* Based on list of Top 50 companies from PharmExec 50, Pharmaceutical Executive Magazine, May 2011** Based on analysis using the Pharmaprojects Database - Pharmaceutical Research & Development Pipeline Intelligence, © Informa UK Ltd ***Based on analysis of list of Top 200 Pharmaceutical Products, The Njardarson Group, Cornell University

Gibco®Cell Culture

POROS®Chromatography

Applied Biosystems®

SEQ Analytics

CellularMedicine

Leader in mAb polish

chromatography

Leader in mAb polish

chromatography

Leader in contaminant and impurity testing

Leader in contaminant and impurity testing

New solutions for cell

therapy, regenerative

medicine

New solutions for cell

therapy, regenerative

medicine

Leader in media and feeds for

50 years

Leader in media and feeds for

50 years

Bioproduction


Bioproduction solutions are used by small to large companies across six continents

Europe31%

Americas34%

Asia Pacific13%

Japan16%

Other6%

Contract Services16%

Large Bio/Pharma57%

Sm/Med Bio/Pharma

14%

Animal Health11%

Designed for Phase 1-3process development

to large-scale manufacturing

Designed for Phase 1-3process development

to large-scale manufacturing

Bioproduction solutionsBioproduction solutions

Revenue, by GeographyRevenue, by Geography Revenue, by Customer SegmentRevenue, by Customer Segment


Vaccines Shift from egg-based to cell culture-based

Biosimilars More drugs coming off patent, need for shorter time to end-user

Cells, Media Standardization of cell lines, demand for shorter timelines, final product quality, higher titers

Product safety Heightened concerns and risk of contamination

Purification bottlenecks Need to support faster scale-up and manufacturing

Cell therapy Need for complete workflow solutions

Ease of use Major shift to disposables in upstream/downstream, automation for analytics

Solutions respond to urgent industry trends


Freedom™ CHO Cell LinesSimplified commercial cell line development

with optimized workflows andunprecedented IP access

Freedom™ CHO Cell LinesSimplified commercial cell line development

with optimized workflows andunprecedented IP access

POROS® XS Chromatography ResinHigh Resolution + High Capacity = Improved YieldPOROS® XS Chromatography ResinHigh Resolution + High Capacity = Improved Yield

resDNASEQ® Host Cell DNA Quantitation System

Same-day results using integrated sample prep, reagents, instruments, and software

Innovations transform bioproduction today

Applied Biosystems® SEQ Analytics POROS® Chromatography Gibco® Cell Culture Cellular Medicine

GMP cellsFriendly IP GMP cells

Friendly IP

Highest resolution +

capacity

Highest resolution +

capacity

Impurity testing in < 5

hours

Impurity testing in < 5

hours


Gibco® Bioproduction Services• Gibco® Process Development Team

• Scientific and business development support• Gibco® Program Management Office

• Singlepoint of contact for order management and execution

• Gibco® PD-Direct Services- Cell line development services- Media development and analytical services

• Gibco® Media Express• Gibco® cGMP Media Custom Services

Technical Support and Services

• On-site technical support• POROS® Customs Services• SEQ Validation and Implementation Services• Cell therapy and stem cell services

Bioproduction Online Community• LIFE Bioproduction homepage• Gibco Media Configurator for web quoting, order tracki

ng• Webinars and educational events• Mobile applications

You

Global Support

Working with us

AccountRepresentative


Worldwide distribution, service and support reach 150 countries on 6 continents

Bioproduction Manufacturing Sites

Grand Island, NY, United StatesCell culture media, reagents, and sera manufacturing

Auckland, New ZealandSera and protein products manufacturing

Newcastle, AustraliaSera manufacturing

SingaporeSequencing and PCR instrumentmanufacturing

Austin, TX, United StatesPharma analytics kit manufacturing

Paisley, ScotlandCell culture media and reagentsmanufacturing

Christchurch, New ZealandProtein products manufacturing

Bedford, MA, United StatesChromatography resins manufacturing

Warrington, EnglandPharma analytics kit manufacturing


bioproduction solutionsfrom molecule to market

Let us take you from molecule to market, so you can take the world from today to tomorrow.

Meet new challenges• Escalating demand for biotherapeutics and vaccines• New cell lines• Heightened concerns about product safety• Emerging biosimilars• Personalized medicine

across multiple therapy classes• Therapeutic protein production• Microbial expression and production• Viral vaccines production• Regenerative medicine• Immunotherapy

using trusted brands• Gibco® cell culture• POROS® chromatography resins• Applied Biosystems® SEQ analytics• Cellular medicine solutions

that set new industry standards• Product quality• Product safety• Fast-to-market efficiency• Dedicated Program Management Office

Meet new challenges• Escalating demand for biotherapeutics and vaccines• New cell lines• Heightened concerns about product safety• Emerging biosimilars• Personalized medicine

across multiple therapy classes• Therapeutic protein production• Microbial expression and production• Viral vaccines production• Regenerative medicine• Immunotherapy

using trusted brands• Gibco® cell culture• POROS® chromatography resins• Applied Biosystems® SEQ analytics• Cellular medicine solutions

that set new industry standards• Product quality• Product safety• Fast-to-market efficiency• Dedicated Program Management Office

Take a molecular leap into the future.


Redefining bioproduction tomorrow

• GMP cell line kits• Media and feeds• Sera and reagents• Contaminant and

impurity assays• Chromatography resins• Services

• GMP cell line kits• Media and feeds• Sera and reagents• Contaminant and

impurity assays• Chromatography resins• Services

TomorrowTomorrowTodayToday

• Functional feeds• Segment-specific

products and services (vaccines, biosimilars, CMOs, cell therapy)

• Omics-based profiling

• Affinity, IEX and custom chromatography

• Functional feeds• Segment-specific

products and services (vaccines, biosimilars, CMOs, cell therapy)

• Omics-based profiling

• Affinity, IEX and custom chromatography

• Protein PCR• Bioburden surveillance• Objectionable organism

panels• Environmental

monitoring programs• Next generation

sequencing applications• Closed automated

platform for cell isolation

• Protein PCR• Bioburden surveillance• Objectionable organism

panels• Environmental

monitoring programs• Next generation

sequencing applications• Closed automated

platform for cell isolation

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Your partner from molecule to marketFocus on both the journey and the destination

• Cell line development• Expression

development

• Media optimization• Process

optimization

Clinicalmanufacturing

Commercial scale-up and

launch

Global manufacturing

• Cell expansion• Fermentation• Viral expansion

Upstream, downstream and analytical solutions for every

stage of the journey

Upstream, downstream and analytical solutions for every

stage of the journey


Freedom™ CHO-S™ cell line kit

Gibco® media and feeds POROS® ChromatographyResins

MicroSEQ™ Microbial Identification System

• Freedom™ CHO cell line kits• Gibco® PD-Direct cell line

development services• POROS® analytical columns• MycoSEQ™ Mycoplasma

Detection System• ViralSEQ® Virus Detection

Assays (MMV, Vesivirus)• MicroSEQ® Microbial

Identification System

• Gibco® media and feeds• Custom cell culture media• Gibco® PD-Direct media

development and analytical services• POROS® analytical columns• GoPure™ disposable columns• MycoSEQ™ Mycoplasma

Detection System• ViralSEQ® Virus Detection Assays

(MMV, Vesivirus, PCV1/PCV2)• MicroSEQ® Microbial


• POROS® polish and capture chromatography resins• GoPure™ disposable

columns• resDNASEQ® Host Cell DNA

Quantitation Assays (CHO,NS0)• MicroSEQ® Microbial

Identification System• ProteinSEQ™ Quantitation

Assay (Protein A, HCP)

• MicroSEQ® Microbial Identification System for bacteria and fungi

BIOPRODUCTION SOLUTIONS

NEEDS

• GMP CHO cell lines• Reproducible high titer

• Rapid assays for key contaminants and impurities• Chemically defined, AOF media and matched feeds

• High capacity, high resolution, salt-tolerant resins for polish chromatography

Molecule-to-market solutions supporting mammalian therapeutic protein production


POROS® analyticalcolumns

resDNASEQ® Host Cell DNA Quantitation Assays

MicroSEQ® MicrobialIdentification System

• POROS® analytical columns• MicroSEQ® Microbial


• Custom media in different formats• POROS® analytical columns• MicroSEQ® Microbial


• POROS® chromatography resins• resDNASEQ® Host Cell DNA

Quantitation Assays (e. coli, Pichia)• GoPure™ disposable columns• MicroSEQ® Microbial



NEEDS

• Host cell lines• Chemically defined media and vectors• Validated and automated rapid contaminant and impurity tests• High capacity, high resolution, salt-tolerant resins for polish chromatography

Molecule-to-market solutions supporting microbial expression and production



Gibco® media developmentand analytical services

resDNASEQ® Host Cell DNA Quantitation Assays

ViralSEQ® Virus Detection Assays

MicroSEQ® MicrobialIdentification System

• ViralSEQ® Virus Detection Assays (MMV, Vesivirus)• Gibco® PD-Direct

media development and analytical services• MicroSEQ® Microbial


• Gibco® media• Custom media in different formats • GoPure™ disposable columns• ViralSEQ® Virus Detection Assays

(MMV, Vesivirus)• Gibco® PD-Direct media

development and analytical services• MicroSEQ® Microbial Identification

System

• POROS® chromatography resins• resDNASEQ® Host Cell DNA

Quantitation Assays (Vero, MDCK)• GoPure™ disposable columns• MicroSEQ® Microbial




NEEDS

• Integrated platform for top human and veterinary vaccine host cells• High cell density, virus titer, and virus stability

Molecule-to-market solutions supportingviral vaccine production


MycoSEQ™ MycoplasmaDetectionSystem

Cell therapy andstem cell services

MycoSEQ™ MycoplasmaDetectionSystem

Dynabeads®immunotherapy products


NEEDS

• Integrated automated platforms• Efficient cell analytics

• Custom solutions• High quality growth

Molecule-to-market solutions supporting cell therapy

• MycoSEQ™ Mycoplasma Detection System• MicroSEQ® Microbial


• Dynabeads® lgG1 Binder CTS• DynaMag™ CTS magnet• MycoSEQ™ Mycoplasma

Detection System• Cell therapy and stem cell services• MicroSEQ® Microbial Identification

System

• MycoSEQ™ Mycoplasma Detection System• Dynabeads® CD3/CD28 CTS

•Media, growth factors, buffers and supplements• Cell therapy and stem cell

services• MicroSEQ® Microbial


• MycoSEQ™ Mycoplasma Detection System• MicroSEQ® Microbial

Identification System for bacteria and fungi


Legal Disclosure

Life Technologies manufactures products labeled for Research Use Only, and for In-Vitro Diagnostic use. Please refer to the Life Technologies website for specific indications and use information for these products.

© 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners.

Life Technologies manufactures products labeled for Research Use Only, and for In-Vitro Diagnostic use. Please refer to the Life Technologies website for specific indications and use information for these products.

© 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners.


Appendix


Media & feeds Cells• CD CHO*• CD OptiCHO™*• CD FortiCHO™*• CHO CD EfficientFeed™ A• CHO CD EfficientFeed™ B*• CD EfficientFeed™ C AGT• Custom media in different formats

(AGT, DPM, liquid, concentrate)*Also available in proprietary Advanced

Granulation Technology™ (AGT™) format

• Freedom™ Cell Line Development Kits- CHO-S™- CHO-DG 44

• Licensing

Sera Reagents & disposables Bioproduction services• Fetal bovine sera• Horse sera• Rabit sera

• rHu Insulin AOF• Buffers• TryPLE™ Reagents• FoamAway™ anti-foaming agents• Gibco® disposable bags

• Gibco® Process Development Team• Scientific and business development

• Gibco® Program Management Office• Order execution and management

• Gibco® PD-Direct Services• Cell line development services• Media development and analytical

services• Gibco® Media Express• Gibco® cGMP Media Custom Services

“Great all around selection of products, great customer service.”Customer survey, 2011

“Great all around selection of products, great customer service.”Customer survey, 2011

Gibco® products and services


Bulk resins Analytical columns Disposable columns

• XS 50 µm Bulk Resin• MabCapture™ A Resin• Heparin 50 µm Bulk Resin• HQ 50 µm Bulk Resin• HS 50 µm Bulk Resin• D 50 µm Bulk Resin• PI 50 µm Bulk Resin• R1 50 µm Bulk Resin• R2 50 µm Bulk Resin

• Protein A 20 µm Columns, PEEK™• Protein G 20 µm Columns, PEEK™• AL 20 µm Columns, PEEK™• EP 20 µm Columns, PEEK™• OH 20 µm Columns, PEEK™• PI 20 µm Columns, PEEK™• HS 20 µm Columns, PEEK™• S 20 µm Columns, PEEK™• MC 20 µm Columns, PEEK™• HP 20 µm Columns, PEEK™• R1 20 µm Columns, PEEK™• R2 20 µm Columns, PEEK™

• GoPure™ 1.2 cm Diameter Column• GoPure™ 8.0 cm Diameter Column• GoPure™ 20 cm Diameter Column

Services• Custom Services

“Their resins can be used at higher flow rates with very good protein binding capacity.”

Customer survey, 2011

“Their resins can be used at higher flow rates with very good protein binding capacity.”


POROS® products and services


Product safety microbiological contaminant analysis

Product quality biologics impurity analysis

Microbial Identification System• MicroSEQ® Rapid Sample Prep• PrepMan® Ultra Sample Prep.

ReagentKits• MicroSEQ® 500 16S rDNA Bacterial

Identification Kit• MicroSEQ® Full Gene 16S rDNA

Bacterial Identification Kit• MicroSEQ® D2 LSU rDNA Fungal

Identification Kit

Instruments• Veriti® 96-Well Thermal Cycler• 3500 Genetic AnalyzerSoftware• MicroSEQ® iD Analysis SoftwareServices• Validation and Implementation

Services

Mycoplasma Detection• MycoSEQ™ Mycoplasma Detection

AssayHost Cell Residual DNA Quantitation• resDNASEQ® Quantitative DNA

System (CHO, NS0, E. coli, Pichia, MDCK, Vero)

Virus Detection• ViralSEQ® Vesivirus Detection

Assay• ViralSEQ® MMV Detection AssayProtein Detection• ProteinSEQ™ Protein Quantitation

Assay

Sample Preparation• PrepSEQ® Mycoplasma Sample

Preparation Kit plus Module M

• PrepSEQ® 1-2-3 Nucleic Acid Extraction Kit

Instruments• 7500 Fast Real-Time PCR System• Automate Express™ Nucleic Acid

Extraction SystemSoftware• AccuSEQ® Real-Time PCR Detection

SoftwareServices• Implementation and Training

Services

“Applied Biosystems® gives the most consistent results, and they have the best technical support for their products”


“Applied Biosystems® gives the most consistent results, and they have the best technical support for their products”


Applied Biosystems® SEQ products and services


Immunotherapy products Stem cell media and reagents

• AIM V® Medium CTS™• OpTmizer™ CTS™ T-Cell Expansion SFM• Dynabeads® CD3⁄CD28 CTS™• DynaMag™ CTS™• Cell Therapy Systems DPBS CTS™

(without Ca and Mg)• Recombinant human growth factors• Cell therapy and stem cell services

• KnockOut™ CTS™ Media• CELLstart™ CTS™ Reagents• DPBS CTS™ Reagents (with Ca and Mg)• TrypLE™ Select CTS™ Reagents• GlutaMAX™-I CTS™ Reagents• Recombinant human growth factors• Cell therapy and stem cell services

Cellular medicine products and services


Best-in-class technology Global technical & sales support

Customer satisfaction State-of-the-art operations

“You can trust this company.”Customer survey, 2011

“You can trust this company.”Customer survey, 2011

“They go all the way to cut red tape and deliver what you need today and not tomorrow .“

“They go all the way to cut red tape and deliver what you need today and not tomorrow .“

Core strengths align with customer needs

Documents

Bioproduction solutions Date Name. 2 8/6/2015 | Life Technologies™ bioproduction solutions bioproduction solutions from molecule to market from molecule